Podcasts

The second day of CRDSA’s 2025 Summit summit was all about the European data space, covering EHDS, various IHI projects, Darwin, and more. Sessions addressed how the initiatives work together (and where they don’t), with a focus on the role of industry, both as data providers and data users.

• Demystifying the EU Data Space   (Keynote)
• EHDS: What’s in store for the European Health Data Space  (Presentation)
• Individual Patient Data Sharing in the EU  (Panel Discussion)

The first day of CRDSA’s 2025 Summit explored the current state of patient data reuse in the regulatory approval process. Presentations and the expert panel discussed why responsible data reuse is a critical tool in future trial design, how the totality of evidence can inform the drug development process, and what’s needed to meet regulatory use challenges.

• C-Path’s use of patient-level data in the regulatory pathway  (Keynote)
• The Intersection of Data Sharing and Equitable Healthcare: Challenges and Opportunities  (Presentation) 
• Innovative Trial Design: Data Reuse Opportunities and Regulatory Considerations  (Panel)

Drawing from their unique perspectives, CRDSA’s board members discuss the foundational elements needed to support a data reuse ecosystem that best serves patients, accelerates drug discovery, and advances human health.

In this original investigation, Dr. Ashley Hopkins (Flinders University) and colleagues, including Frank Rockhold (Duke CRI and CRDSA Board Director) and Aaron Mann (CRDSA), address the utility and completeness of individual-participant data (IPD) and the supporting documents provided from industry-sponsored clinical trials. The study includes IPD packages received from 70 of 91 eligible clinical oncology trials (77%) for a planned meta-analysis. The analysis indicated substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.

Regulatory Focus, a publication of Regulatory Affairs Professional Society (RAPS), interviews CRDSA CEO Aaron Mann and COTA Healthcare’s Chief Medical Officer C.K. Wang, MD, on CRDSA’s demonstration project that seeks to establish best practices around the use of clinical trial and real-world data (RWD) in building supplemental control arms.

In this episode of the IEEE Standard Association’s “Re-Think Health” Podcast Series, Aaron Mann and Maria Polombini discuss how open data sharing is paving the way to access more quality, real-world and inclusive data to enable predictivity analytics to be more accurate, resourceful, and utilitarian in the world of clinical research.

This article in Clinical Leader discusses the challenges faced across the clinical data sharing ecosystem and how CRDSA’s Work Streams are addressing these challenges.